# K212470: iRAD

- Pathway: 510(k) (Traditional)
- Applicant: Claritas Healthtech Pte, Ltd.
- Decided: Oct 20, 2021 after 75 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922470 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172768: ZOOM, Zetta Medical Technologies, LLC (2018) Summary page 4.

## Indications for use
iRAD Image Enhancement System is an image processing software than can be used for image enhancement of MRI, CT, and X-Ray images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.

Source page: https://510kreport.com/device/K212470
Methodology: https://510kreport.com/methodology